Clinical trials are conducted to collect data regarding the safety and efficacy of new drug and device development. There are several steps and stages of approval in the clinical trials process before a drug or device can be sold in the consumer market.
Phase I
During phase I of a clinical trial, investigators spend several months looking at the effects of the medication on about 20 to 80 people who have no underlying health conditions.
The goal of this phase is to determine the optimal dose humans can take without side effects. During this phase the investigators monitor participants very closely to see how their bodies react to the medication.
Phase II
Phase II of a clinical trial involves several hundred participants living with the condition the new medication is designed (or intended) to treat.
The participants are given the medication and monitored for several months or years in order to gather additional information regarding possible side effects.
Phase III
Phase III of a clinical trial usually involves up to 3,000 participants who have the condition that the new medication is meant to treat. Trials in this phase can last for several years.
The purpose of phase III is to evaluate how the new medication works in comparison to existing medications for the same condition. To move forward with the trial, investigators need to demonstrate that the medication is at least as safe and effective as existing treatment options.